Prelidopine Pre-operative System
NDC Package 70529-124-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Prelidopine Pre-operative System is lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. Marketed by It3 Medical Llc, this product is identified by NDC 70529-124 and is authorized under FDA application ANDA088327.

Identification & Billing

NDC Package Code
70529-124-01
Package Description
1 KIT in 1 PACKAGE * 20 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET
Product Code
70529-124
11-Digit Billing Format
70529012401
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Prelidopine Pre-operative System
Dosage Form
-
Usage Information
Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.

Regulatory & Marketing

Labeler Name
It3 Medical Llc
FDA Application #
ANDA088327
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-01-2017
Listing Expiration
12-31-2023
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70529-124-01 identifies a specific commercial package of 1 kit in 1 package * 20 ml in 1 vial, multi-dose * 1 ml in 1 packet of Prelidopine Pre-operative System, labeled by It3 Medical Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by It3 Medical Llc on March 01, 2017. The current certification is valid through December 31, 2023.

How is this It3 Medical Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70529012401. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
70529-124-01
11-Digit CMS (5-4-2)
70529-0124-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.